A comparison of two treatment regimes for the treatment of fungal eye infections in East Africa

Not Applicable

• Conditions: Fungal keratitis; Eye Diseases; Keratitis

• Registration Number: ISRCTN87195453
• Lead Sponsor: ondon School of Hygiene & Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-27
• Last Update Posted: 30 January 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

1. Acute microbial keratitis characterised by:
1.1 Corneal epithelial ulceration >1 mm diameter
1.2 Corneal stromal infiltrate
1.3 Acute inflammation: e.g. conjunctival injection, anterior chamber inflammatory cells, hypopyon
2. Filamentous fungal hyphae visualised on smear microscopy and/or in vivo confocal microscopy
3. Agree to be randomised to either treatment arm and able to give informed consent
4. Agree to be followed up at 2 days, 1 week, 2 weeks, 3 weeks, 2 months and 3 months
5. Adults (18 years and older)

Exclusion Criteria

Current exclusion criteria as of 08/09/2021:

1. Unwilling to participate in trial or attend follow-up
2. Aged less than 18 years
3. Pregnancy: self-reported, or by urine hCG pregnancy test if uncertain. 4. Breast feeding: selfreported
5. No light perception in the affected eye
6. Fellow eye visual acuity <6/60
7. Acanthamoebic infection visualised by smear microscopy or IVCM
8. Clinical evidence of herpetic keratitis
9. Known allergy to study medication (including preservatives)
10. Previous penetrating keratoplasty in the affected eye
11. Bilateral corneal ulcers
12. Nationals of another country
13. Very severe ulcers warranting immediate evisceration or conjunctival flap
14. Fungal Endophthalmitis

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Previous exclusion criteria:

1. Pregnancy: self-reported, or by urine hCG pregnancy test if uncertain
2. Breast feeding: self-reported
3. Prior topical anti-fungal treatment
4. No light perception in the affected eye
5. Fellow eye visual acuity <6/60
6. Acanthamoebic infection visualised by smear microscopy or IVCM
7. Clinical evidence of herpetic keratitis
8. Known allergy to study medication (including preservatives)
9. Previous penetrating keratoplasty in the affected eye
10. Bilateral corneal ulcers
11. Very severe ulcers warranting immediate evisceration or conjunctival flap
12. Fungal Endophthalmitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified